BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS MRI

    MDR report key: 2812108 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16415
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    September 25, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY (B)(4): THE FULL LEAD WAS RETURNED TO THE MANUFACTURER AND ANALYZED. THE DISTAL CONDUCTOR WAS DISTORTED AND FRACTURED (OVERSTRESS.) ALL CONDUCTORS HAD BLOOD/BODY FLUID (NOT OBSTRUCTED); THE INNER INSULATION AND INNER TUBING WAS KINKED BUCKLED. THE OUTER INSULATION WAS BREACHED CUT AND HAD COSMETIC DEPRESSION. THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM AND THE LEAD WAS STRETCHED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON PRE-DISCHARGE CHECK, FOLLOWING A DEVICE UPGRADE PROCEDURE, ATRIAL CAPTURE WAS NOT POSSIBLE AT MAX OUTPUT WITH THE CHRONIC RIGHT ATRIUM (RA) LEAD. IT WAS ALSO REPORTED THAT X-RAY IDENTIFIED SIGNIFICANT SLACK LOSS IN THE RA LEAD. IT WAS FURTHER REPORTED THAT REPOSITIONING ATTEMPT OF THE RA LEAD WAS UNSUCCESSFUL BECAUSE THE HELIX WOULD NOT RETRACT. THEREFORE THE RA LEAD WAS REMOVED AND REPLACED WITH A NEW LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSUREFIX NOVUS MRI IMPLANTABLE PACING LEAD NVN MEDTRONIC PUERTO RICO, INC. 5086MRI

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 4296 IMPLANTABLE PACING LEAD| 6947 IMPLANTABLE TACHY LEAD